Vascular hole closure device

0001This application claims priority from provisional application serial no. 61/330,477, filed May 3, 2010 and is a continuation in part of application no. 12/854,988, filed Aug. 12, 2010 now abandoned, which claims priority from provisional application ser. no. 61/241,555 filed Sep. 11, 2009, and is a continuation in part of application ser. no. 12/358,411, filed Jan. 23, 2009, now U.S. Pat. No. 8,070,772, which claims priority from provisional application serial no. 61/066,072, filed Feb. 15, 2008.

BACKGROUND

00021. Technical Field

0003This application relates to a vascular device and more particularly to a device for closing openings in vessel walls.

00042. Background of Related Art

0005During certain types of vascular surgery, catheters are inserted through an incision in the skin and underlying tissue to access the femoral artery in the patient's leg. The catheter is then inserted through the access opening made in the wall of the femoral artery and guided through the artery to the desired site to perform surgical procedures such as angioplasty or plaque removal. After the surgical procedure is completed and the catheter is removed from the patient, the access hole must be closed. This is quite difficult not only because of the high blood flow from the artery, but also because there are many layers of tissue that must be penetrated to reach the femoral artery.

0006Several approaches to date have been used to close femoral access holes. In one approach, manual compression by hand over the puncture site is augmented by a sandbag or weight until the blood coagulates. With this approach, it can take up to six hours for the vessel hole to close and for the patient to be able to ambulate. This inefficiency increases the surgical procedure time as well as the overall cost of the procedure since the hospital staff must physically maintain pressure and the patient's discharge is delayed because of the inability to ambulate.

0007In another approach to close the vessel puncture site, a clamp is attached to the operating table and the patient's leg. The clamp applies pressure to the vessel opening. The patient, however, must still be monitored to ensure the blood is coagulating, requiring additional time of the hospital staff and increasing the cost of the procedure.

0008To avoid the foregoing disadvantages of manual pressure approaches, suturing devices have been developed. One such suturing device, referred to as “the Closer” and sold by Perclose, advances needles adjacent the vessel wall opening and pulls suture material outwardly through the wall adjacent the opening. The surgeon then ties a knot in the suture, closing the opening. One difficulty with the procedure involves the number of steps required by the surgeon to deploy the needles, capture the suture, withdraw the suture, and tie the knot and secure the suture. Moreover, the surgeon cannot easily visualize the suture because of the depth of the femoral artery (relative to the skin) and essentially ties the suture knot blindly or blindly slips a pre-tied knot into position. Additionally, the ability to tie the knot varies among surgeons; therefore success and accuracy of the hole closure can be dependent on the skill of the surgeon. Yet another disadvantage of this suturing instrument is that the vessel opening is widened for insertion of the instrument, thus creating a bigger opening to close in the case of failure to deliver the closure system. It is also difficult to pass the needle through calcified vessels.

0009U.S. Pat. No. 4,744,364 discloses another approach for sealing a vessel puncture in the form of a device having an expandable closure member with a filament for pulling it against the vessel wall. The closure member is held in place by a strip of tape placed on the skin to hold the filament in place. However, the closure device is still subject to movement which can cause leakage through the puncture. Additionally, if the suture becomes loose, the closure member is not retained and can flow downstream in the vessel. Moreover, since the suture extends through the skin, a potential pathway for infection is created. The closure device in U.S. Pat. No. 5,545,178 includes a resorbable collagen foam plug located within the puncture tract. However, since coagulation typically takes up to twenty minutes and blood can leak in between the plug and tissue tract, manual pressure must be applied to the puncture for a period of time, until the collagen plug expands within the tract.

0010It would therefore be advantageous to provide a device which would more quickly and effectively close openings (punctures) in vessel walls. Such device would advantageously avoid the aforementioned time and expense of applying manual pressure to the opening, simplify the steps required to close the opening, avoid widening of the opening, and more effectively retain the closure device in the vessel.

0011Commonly assigned co-pending patent application Ser. No. 10/847,141, filed May 17, 2004, discloses effective vascular hole closure devices which have the foregoing advantages. It would be further advantageous to provide a vascular hole closure device which is adjustable to accommodate different tissue thicknesses and applies a more constant clamping/retaining force between the intravascular and extravascular components of the device irrespective of tissue thickness.

SUMMARY

0012The present invention provides a device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall. The device comprises a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture, and having a dimension to prevent egress of fluid through the aperture. A securing member is positionable external of the vessel. The securing member has a plurality of pores extending therethrough. A flexible connecting member operatively connects the covering member and the securing member and moves the securing member toward the covering member.

0013In some embodiments, the covering member has a first opening, the first opening configured to restrict movement of the connecting member. A second flexible connecting member could be provided for moving the securing member toward the covering member.

0014In some embodiments, the covering member is composed of a resorbable material. In some embodiments, the securing member is composed of a mesh material. In some embodiments, the securing member is composed of a resorbable material. The connecting member can also be composed of a resorbable material.

0015In one embodiment, the securing member is substantially disc shaped in configuration. In another embodiment, the securing member is substantially rectangular in configuration.

0016The device can further include one or more retainers positioned proximally of the securing member. The device can also include first and second retainers. The retainer(s) can be spherical shaped, bullet shaped, pill shaped or other configurations. The connecting member can be connected to the retainer(s) to move the retainer(s) and securing member toward the covering member.

0017In another aspect, the present invention provides a device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall. The device comprises a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture. First and second retainers are positionable external of the vessel. A flexible connecting member connects the first retainer to the covering member. A porous material is positioned between the retainers and the covering member. Preferably, pulling of the connecting member advances the first retainer toward the covering member.

0018In some embodiments, the covering member has an opening configured to restrict movement of the connecting member. In these embodiments, the connecting member can extend through first and second openings of the covering member and be connected to the securing member. The first opening can be configured to frictionally retain the connecting member to retain the position of the securing member with respect to the covering member.

0019The device may include a second flexible connecting member connecting the securing member to the covering member.

0020Preferably, the covering member is pivotable between a more longitudinal orientation for delivery and a transverse position for placement.

BRIEF DESCRIPTION OF THE DRAWINGS

0021Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:

0022<figref idref="DRAWINGS">FIG. 1</figref> is a perspective view of a first embodiment of the closure device of the present invention;

0023<figref idref="DRAWINGS">FIG. 2</figref> is a cross-sectional view illustrating the suture extending through the covering member of <figref idref="DRAWINGS">FIG. 1</figref>;

0024<figref idref="DRAWINGS">FIG. 3</figref> is a perspective view of the embodiment of <figref idref="DRAWINGS">FIG. 1</figref> illustrating the sutures pulled proximally to move the securing member, toward the covering member adjacent the outer surface of the vessel wall;

0025<figref idref="DRAWINGS">FIG. 4</figref> is a perspective view of an alternate embodiment of the closure device of the present invention;

0026<figref idref="DRAWINGS">FIG. 5</figref> is a perspective view of another alternate embodiment of the closure device of the present invention;

0027<figref idref="DRAWINGS">FIG. 6</figref> is a perspective view of yet another alternate embodiment of the closure device of the present invention; and

0028<figref idref="DRAWINGS">FIG. 7</figref> is a perspective view of another alternate embodiment of the closure device of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

0029Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views, <figref idref="DRAWINGS">FIG. 1</figref> is a perspective view of a first embodiment of the vascular hole (aperture) closure device of the present invention. The device is intended to close an aperture in the vessel wall, typically formed after removal of a catheter previously inserted through the vessel wall into the vessel lumen for performing angioplasty or other interventional procedures. The aperture extends through the patient's skin and underlying tissue, through the external wall of the vessel, through the wall of the vessel, and through the internal wall of the vessel to communicate with the internal lumen of the vessel. The closure device of the present invention has an intravascular component to block blood flow and an extravascular component to retain the intravascular component.

0030More specifically, the closure device includes a covering member or patch positioned within the vessel against the internal wall of the vessel to block blood flow and a securing member with openings or pores positioned external of the vessel wall to retain the covering member in its blocking position. The securing member is fixedly attached to a flexible connecting member such as a suture such that pulling of the suture advances the attached securing member toward the covering member to ultimately position the securing member either against or adjacent the external surface of the vessel wall. The plurality of pores in the securing member facilitates movement toward the covering member as tissue can enter between the pores. Thus, the fat molecules can enter allowing the securing member to track down easier through the tissue tract.

0031Turning to <figref idref="DRAWINGS">FIGS. 1-3</figref>, a first embodiment of the closure device of the present invention is illustrated. Hole (aperture) closure device <b>10</b> has a covering member or patch <b>40</b> and a securing member <b>20</b>. The securing member <b>20</b> in this embodiment is in the form of a disc having substantially planar upper and lower surfaces <b>24</b>, <b>26</b>, respectively. although radiused surfaces or irregular surfaces are also contemplated. Covering member or patch <b>40</b> is dimensioned and configured for positioning inside the vessel on the internal side of the vessel aperture against the internal wall of the vessel; the securing member <b>20</b> is configured to be positioned outside the vessel wall adjacent or contiguous the external side of the vessel aperture.

0032Covering member <b>40</b>, preferably elongated in configuration as shown, is retained in a delivery sheath in a longitudinal position for delivery to the vessel, and then pivots to a transverse position within the vessel lumen (substantially perpendicular to an axis extending through the aperture) for orientation to cover (patch) the vessel aperture on the internal side. This movement is illustrated in FIGS. 37A-37D of commonly assigned co-pending patent application Ser. No. 10/847,141, filed May 17, 2004, issued as U.S. Pat. No. 7,662,661, the entire contents of which are incorporated herein by reference (hereinafter the '141 application).

0033The elongated covering member <b>40</b> functions to cover (patch) the internal opening in the vessel wall to prevent the egress of blood. With reference to <figref idref="DRAWINGS">FIG. 1</figref>, the covering member <b>40</b> is preferably somewhat oval shaped with elongated substantially parallel side walls <b>42</b><i>a</i>, <b>42</b><i>b </i>and end walls <b>49</b><i>a</i>, <b>49</b><i>b</i>, illustratively curved, connecting the side walls <b>42</b><i>a</i>, <b>42</b><i>b</i>. Other shapes of the covering member are also contemplated. Covering member preferably has a thicker region <b>43</b> in the central region than the first and second end regions <b>45</b>, <b>47</b>. Other dimensions are also contemplated.

0034The longitudinal axis of covering member <b>40</b> defines a lengthwise dimension and transverse axes define a shorter widthwise dimensions. The widthwise dimension of the covering member <b>40</b> can be for example about 2.5 mm (for a 6 Fr device). In a preferred embodiment, the covering member <b>40</b> is about 3.1 mm in widthwise dimension. Other dimensions are also contemplated. The width preferably is at least substantially equal to the dimension of the internal opening in the vessel wall to effectively cover the opening. In a preferred embodiment, the covering member <b>40</b> has a length of about 8.6 mm (in a 6 French system). Other dimensions are also contemplated.

0035It should be appreciated that alternatively the covering member could be provided with an enlarged width region as illustrated in the embodiment of FIG. 1 of the '141 application. The covering member could also be configured asymmetrically so that the enlarged region is off-centered to accommodate widening of the aperture as the member is pulled at an angle. The covering member could also be configured in a paddle shape with a narrowed region adjacent a wider region as in FIGS. 9B-9E of the '141 application. Other covering member configurations including those disclosed in the '141 application could be utilized with the securing members of the present application.

0036The elongated covering member can be composed of materials such as polycarbonate or polyurethane. Preferably it is composed of resorbable materials such as lactide/glycolide copolymers that after a period of time resorb in the body. If composed of resorbable material, the covering member could optionally have regions of varying resorbability. Varying degrees of resorbability can be achieved for example by utilizing different materials having differing resorbable characteristics or by varying the mass of the covering member (increased mass increases resorbtion time).

0037Securing member <b>20</b> is preferably composed of resorbable material. The securing member can be composed of a material having a plurality of pores extending therethrough. This can include a mesh, braid, or weave for example. It can also include a more solid material having pores formed therethrough. Materials include Polydioxanone (PDO), Polylactic acid (PLA), Polyglycolic Acid (PGA), Poly(lactic-co-glycolic acid) (PLGA), Polyhydroxyalkanoates (PHA), and Polycaprolactone (PCL), although other materials are contemplated. It could also be made of non-absorbable polymeric or metallic material.

0038When the securing member <b>20</b> is released from the delivery instrument, it is spaced further from the covering member <b>40</b>. It is configured to then be advanced toward the covering member <b>40</b>. More specifically, securing member <b>20</b> is fixedly secured to flexible connecting members illustratively in the form of suture <b>30</b> and <b>32</b>. Sutures <b>30</b>, <b>32</b> are preferably made of polymeric material and are preferably resorbable, composed of a material such as polydioxanome. It is also contemplated that alternatively a metallic material could be utilized. It is also contemplated that a single suture could be utilized to advance the covering member.

0039As shown, suture <b>30</b> has a free end <b>30</b><i>a </i>and an opposite end <b>30</b><i>b </i>secured to securing member <b>20</b> by molding, gluing, forming a knot, or other methods. Similarly, suture <b>32</b> has a free end <b>32</b><i>a </i>and an opposite end <b>32</b><i>b </i>secured to securing member <b>22</b> in a similar manner. The sutures <b>30</b>, <b>32</b> are looped through the covering member <b>40</b>. Other methods of attachment are also contemplated. For example, the sutures can be attached to covering member by a loop of suture as shown for example in FIG. 8 of co pending patent application Ser. No. 12/854,988, filed Aug. 12, 2010 (hereinafter the “'988 application”), incorporated herein by reference in its entirety.

0040To advance the securing member <b>20</b> toward the vessel wall W (and covering member <b>40</b>), the free end <b>30</b><i>a</i>, <b>32</b><i>a </i>of each suture is pulled proximally (in a direction of the arrows of <figref idref="DRAWINGS">FIG. 3</figref>, thereby moving the securing member <b>20</b> in the opposite direction closer to the aperture and vessel wall. The pores of securing member <b>20</b> facilitate advancement toward the covering member <b>40</b> as tissue can enter between the pores as it is advanced. Once tightened against the tissue, a sufficient retention force is maintained, i.e. a proximal pulling force on the covering member <b>40</b> to pull it slightly upwardly (proximally) against the vessel wall. The securing member <b>20</b> therefore helps to prevent the covering member <b>40</b> from separating from the vessel wall (e.g. moving in the direction toward the opposing vessel wall) which could create an unwanted gap between the covering member <b>40</b> and the vessel opening to allow blood flow. The extent to which the securing member <b>20</b> moves toward the wall (and thus the distance from the vessel wall in its final placement position) will depend on the tissue thickness. Thus, the closure device <b>10</b> can adjust for different tissue thicknesses and apply a constant retention force regardless of tissue thickness.

0041The delivery instrument for inserting the closure device extends through an opening in the skin, through the tissue tract to the vessel, through an external opening in the vessel wall, through the aperture in the vessel wall, and through an internal opening on the internal side of the vessel wall into the vessel lumen.

0042The covering member <b>40</b> is outside a retainer tube and within a delivery sheath in a tilted position in a manner similar to FIGS. 2 and 3 of the '988 application. The covering member <b>40</b> emerges from the sheath and moves from a tilted and preferably a somewhat straightened positioned, (substantially aligned with the longitudinal axis of the sheath) to a transverse position within the vessel (see the orientation of <figref idref="DRAWINGS">FIG. 3</figref>). (Note the vessel wall is shown in <figref idref="DRAWINGS">FIG. 3</figref> but the rest of the vessel and tissue are removed for clarity.) The securing member <b>20</b> remains within the tube in a tilted somewhat straightened position. In some embodiments, the securing member <b>20</b> can be retained within the tube in a folded or compressed configuration. Note the covering member <b>40</b> can be ejected by a pusher (not shown) contacting the side or top wall of the covering member <b>40</b>.

0043As shown in <figref idref="DRAWINGS">FIG. 3</figref>. covering member <b>40</b> is pulled proximally to abut the internal opening on the internal side of the vessel W to cover (patch) the opening and the sutures <b>30</b>, <b>32</b>, extend through the opening A in the vessel wall. The securing member <b>20</b> is ejected from the sheath by advancing the securing member <b>20</b>, retracting the sheath or relative movement of both to free the securing member <b>20</b> from the confines of the sheath. As noted above, in the delivery position. the securing member <b>20</b> is preferably in a tilted position (not shown) to minimize the transverse dimension of the delivery system and tilts to a transverse deployment position when exposed from the delivery sheath. As also noted above, the securing member <b>20</b> can alternatively or additionally be held in a folded or compressed position.

0044Then, to retain the covering member <b>40</b> in position against the vessel wall to block blood flow therethrough. sutures <b>30</b> and <b>32</b> are pulled proximally from their free ends <b>30</b><i>a</i>, <b>32</b><i>a</i>, in the direction of arrows of <figref idref="DRAWINGS">FIG. 3</figref> thereby advancing the securing member <b>20</b> distally in the direction toward the aperture A, vessel wall W and covering member <b>40</b>. As shown, the securing member <b>20</b> can be moved to a position contiguous to the vessel wall, or depending on tissue thickness, may be adjacent the wall with some tissue interposed between the securing member <b>20</b> and vessel wall. The securing member <b>20</b> in this position applies a proximal (upward) force on the elongated covering member <b>40</b> to limit movement of the covering member into the vessel.

0045The covering member <b>40</b> has a first pair of holes <b>44</b><i>a</i>, <b>44</b><i>b </i>and a second pair of holes <b>46</b><i>a</i>, <b>46</b><i>b</i>. The first pair of holes <b>44</b><i>a</i>, <b>44</b><i>b </i>receive suture <b>32</b> and the second pair of holes <b>46</b><i>a</i>, <b>46</b><i>b </i>receive suture <b>30</b>. Holes <b>44</b><i>b</i>, <b>46</b><i>b </i>have a smaller diameter than holes <b>44</b><i>a</i>, <b>46</b><i>a</i>, respectively. The larger hole <b>46</b><i>a </i>is dimensioned to receive suture <b>30</b> for free unrestricted movement of the suture <b>30</b> therethrough and therefore easier application of securing member <b>20</b>. Similarly, the larger hole <b>44</b><i>a </i>is dimensioned to receive suture <b>32</b> for free unrestricted movement of the suture <b>32</b> therethrough. Smaller hole <b>46</b><i>b </i>is dimensioned to frictionally engage suture <b>30</b> so that tension is applied to the suture <b>30</b>. It is dimensioned so that the suture <b>30</b> can be pulled through the hole <b>46</b><i>b </i>if sufficient force is applied by pulling on free end <b>30</b><i>a</i>, but if such predetermined force is not applied, the suture <b>30</b> will remain frictionally engaged within the wall of the hole <b>46</b><i>b </i>and not move, and thus securing member <b>20</b> will not move. Hole <b>44</b><i>b </i>operates similarly with respect to suture <b>32</b>, allowing movement if a predetermined force is applied but remain frictionally engaged if such force is not applied. In this manner, when the user ceases pulling on free ends <b>30</b><i>a </i>and <b>32</b><i>a </i>of sutures <b>30</b>, <b>32</b> respectively, the securing member <b>20</b> will remain in position. <figref idref="DRAWINGS">FIG. 2</figref> shows how the suture <b>30</b> is looped through the respective opening.

0046To enhance the retention of the suture of the present invention within the smaller diameter hole, a plurality of internal teeth can be provided. This is shown for example in FIGS. 22 and 23 of the '988 application wherein hole 496a′ has a plurality of teeth <b>497</b> formed on the interior wall of the smaller opening. Engagement of the suture <b>430</b>′ by the teeth <b>497</b> retains the suture and retainer. Note that the teeth can be formed to angle inwardly so the suture can be moved in only one direction, i.e. proximally so the retainer is advanced toward the covering member.

0047The alternate embodiment of <figref idref="DRAWINGS">FIG. 4</figref> of the present invention is identical to the embodiment of <figref idref="DRAWINGS">FIG. 1</figref> except for the configuration of the securing member. Thus, closure device <b>100</b> has a covering member or patch <b>140</b> identical to patch <b>40</b>, sutures (flexible connecting members) <b>130</b>, <b>132</b> (with free ends <b>130</b><i>a</i>, <b>132</b><i>a</i>) identical to sutures <b>30</b>, <b>32</b> and openings <b>146</b><i>a</i>, <b>146</b><i>b </i>and <b>144</b><i>a</i>, <b>144</b><i>b </i>identical to openings <b>46</b><i>a</i>, <b>46</b><i>b</i>, <b>44</b><i>a</i>, and <b>44</b><i>b</i>. Therefore, further detail of these components and their function, for brevity, will not be repeated herein. The securing member <b>120</b> differs from securing member <b>20</b> of <figref idref="DRAWINGS">FIG. 1</figref> in that it is substantially rectangular in shape. Securing member <b>120</b> can optionally have substantially planar upper and lower surfaces <b>124</b>, <b>126</b>, although other surfaces can be provided, e.g. curved, concave, convex, etc. The pores in securing member <b>120</b> facilitate movement in the same manner as described above. The securing member <b>120</b> can be made of the same materials as discussed above with respect to securing member <b>20</b>. Sutures <b>130</b>, <b>132</b> advance securing member <b>120</b> toward covering member <b>140</b> in the same manner as sutures <b>30</b>, <b>32</b> discussed above.

0048The alternate embodiment of <figref idref="DRAWINGS">FIG. 6</figref> is identical to the embodiment of <figref idref="DRAWINGS">FIG. 1</figref> except for the configuration of the securing member. Thus, closure device <b>200</b> has a covering member or patch <b>240</b> identical to patch <b>40</b>, sutures (flexible connecting members) <b>230</b>, <b>232</b> (with free ends <b>230</b><i>a</i>, <b>232</b><i>a</i>) identical to sutures <b>30</b>, <b>32</b> and openings <b>246</b><i>a</i>, <b>246</b><i>b </i>and <b>244</b><i>a</i>, <b>244</b><i>b </i>identical to openings <b>46</b><i>a</i>, <b>46</b><i>b</i>. <b>44</b><i>a</i>, and <b>44</b><i>b</i>. Therefore, further detail of these components and their function, for brevity, will not be repeated herein. The securing member <b>220</b> is shaped similarly to patch <b>240</b> (except inverted) with a thicker central region <b>225</b> and substantially parallel side walls <b>227</b>, <b>229</b> connected by radiused walls <b>226</b><i>a</i>, <b>226</b><i>b</i>. An opening <b>223</b> in central region <b>225</b> facilities advancement as tissue can enter the opening <b>223</b> as securing member <b>220</b> is advanced. Additional openings or pores could also be provided to facilitate movement. The securing member <b>220</b> can be made of the same materials as discussed above with respect to securing member <b>20</b>. Sutures <b>30</b>, <b>32</b> advance securing member <b>220</b> toward covering member <b>240</b> in the same manner as sutures <b>230</b>, <b>232</b> discussed above.

0049In the embodiment of <figref idref="DRAWINGS">FIG. 5</figref>, hole closure device <b>300</b> has a covering member or patch <b>340</b> substantially identical to patch <b>40</b> and a securing member <b>320</b> with pores similar to securing member <b>120</b> of <figref idref="DRAWINGS">FIG. 3</figref> to facilitate advancement. Openings <b>346</b><i>a</i>, <b>344</b><i>a </i>are larger than openings <b>346</b><i>b</i>, <b>344</b><i>b</i>. The openings are dimensioned to receive sutures (flexible connecting members) <b>330</b>, <b>332</b>. That is, suture <b>330</b> extends through openings <b>346</b><i>a </i>and <b>344</b><i>b </i>and suture <b>332</b> extends through openings <b>344</b><i>a</i>, <b>344</b><i>b</i>. Sutures <b>330</b>, <b>332</b>, have free ends <b>330</b><i>a</i>, <b>332</b><i>a</i>, respectively. Openings <b>344</b><i>b </i>and <b>346</b><i>b </i>have a smaller dimension to frictionally engage the suture as described above with respect to openings <b>44</b><i>b</i>, <b>46</b><i>b </i>of <figref idref="DRAWINGS">FIG. 1</figref>. First and second retainers <b>360</b>, <b>370</b> are spherical shaped and positioned proximally of securing member <b>320</b>, but it is also contemplated other shaped retainers could be utilized, e.g. cylindrical, pill shaped, etc. Optionally one retainer could be provided. Thus, securing member <b>320</b> is interposed between the retainers <b>360</b>, <b>370</b> and patch <b>340</b>. The sutures <b>330</b>, <b>332</b> are attached at one end to retainers <b>360</b>, <b>370</b>, respectively and can extend through pores in the securing member <b>320</b> to loop through covering member <b>340</b>. The securing member <b>320</b> remains external of the vessel opening and further functions as an extravascular component to block the retainers <b>360</b>, <b>370</b> from extending through the vessel opening into the vessel. Proximal force applied to sutures <b>330</b>, <b>332</b> at their free ends <b>330</b><i>a</i>, <b>332</b><i>a </i>advances retainers <b>360</b>, <b>370</b> toward covering member <b>340</b> in the same manner as sutures <b>30</b>, <b>32</b> of <figref idref="DRAWINGS">FIG. 1</figref> advance securing member <b>20</b>, due to their attachment to retainers <b>360</b>, <b>370</b> at their opposite end. As retainers <b>360</b>, <b>370</b> are advanced toward covering member <b>340</b> they force securing member <b>320</b> toward covering member <b>340</b> due to their engagement (abutment) with the proximal surface <b>321</b> of securing member <b>320</b>.

0050In the embodiment of <figref idref="DRAWINGS">FIG. 7</figref>, a single retainer <b>420</b> is provided in the form of a substantially cylindrical shaped member having pores to facilitate movement as described above. Member <b>420</b> is attached to a first portion of suture (flexible connecting member) <b>430</b> by a suture loop <b>432</b> extending through the pores or through openings in retainer <b>420</b> and looped as shown. Suture <b>430</b> extends through a channel in member <b>420</b> and extends through large opening <b>444</b><i>a </i>in covering member or patch <b>440</b>, exiting smaller opening <b>444</b><i>b</i>, terminating in free end <b>430</b><i>a</i>. Thus, free end <b>430</b><i>a </i>of suture <b>430</b> is pulled proximally, pulling retainer <b>420</b> toward covering member <b>440</b>, with the smaller opening <b>444</b><i>b </i>frictionally retaining the suture <b>430</b> in the same manner as opening <b>44</b><i>b </i>in <figref idref="DRAWINGS">FIG. 1</figref> to restrict movement.

0051While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.